Needle assembly for tissue manipulation

Abstract

Needle assemblies for tissue manipulation are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. A needle deployment assembly is deployable through the tissue manipulation assembly via a handle assembly, through the tubular member, and into or through tissue. An elongate pusher is translationally disposed within a sheath of the needle deployment assembly and can be urged distally for deploying an anchor assembly from the sheath distal end. The anchor assembly is positioned distally of the pusher within the sheath.

What is claimed is: 
     
       1. A needle assembly for use in forming a tissue fold, comprising:
 a housing having a shuttle member enclosed within; 
 an elongate pusher attached to the shuttle member and extending from a distal end of the housing; 
 a tubular sheath having a first lumen adapted to receive the elongate pusher therethrough and having a proximal end which is attachable to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible distal region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is substantially transverse to the longitudinal axis; 
 an actuation member disposed on the housing, wherein articulation of the actuation member translates the elongate pusher longitudinally relative to the housing; 
 a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath; 
 at least one anchor positioned distally of the elongate pusher; and 
 a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members; 
 wherein said needle body has a first position in which the needle body is located outside of the space between said first and second extension members and a second position in which the needle body is located within the space between said first and second extension members. 
 
     
     
       2. The assembly of  claim 1  wherein the housing comprises a cylindrically-shaped member. 
     
     
       3. The assembly of  claim 1  wherein the housing defines at least one projection extending therefrom for retaining the needle assembly within a handle. 
     
     
       4. The assembly of  claim 1  wherein the housing comprises an indicator which is indicative of a position of the shuttle member within the housing. 
     
     
       5. The assembly of  claim 4  wherein the indicator comprises a translatable visual marker which is visible through a window defined along a length of the housing. 
     
     
       6. The assembly of  claim 4  further comprising one or more gradations along a length of the housing. 
     
     
       7. The assembly of  claim 1  wherein the elongate pusher is connected to the shuttle member. 
     
     
       8. The assembly of  claim 1  wherein the elongate pusher is flexible. 
     
     
       9. The assembly of  claim 1  wherein the shuttle member comprises a threaded member adapted to be linearly translated over a rotatable threaded shaft. 
     
     
       10. The assembly of  claim 1  further comprising a lubricious lining or coating along an inner surface of the tubular sheath. 
     
     
       11. The assembly of  claim 1  wherein the tubular sheath comprises a translucent material. 
     
     
       12. The assembly of  claim 1  wherein the proximal end of the tubular sheath is adapted to be releasably attached to a distal end of the housing. 
     
     
       13. The assembly of  claim 1  wherein a distal end of the tubular sheath is tapered. 
     
     
       14. The assembly of  claim 1  wherein the actuation member is rotatably disposed on a proximal end of the housing. 
     
     
       15. The assembly of  claim 1  wherein the at least one anchor has a low-profile delivery configuration when positioned within the tubular sheath and an expanded configuration when deployed from the tubular sheath. 
     
     
       16. The assembly of  claim 1  wherein said at least one anchor comprises at least two anchors, and further comprising a length of suture between at least two of the anchors. 
     
     
       17. The assembly of  claim 16  further comprising a locking mechanism adapted to slide uni-directionally over the suture in a direction towards the anchor. 
     
     
       18. An apparatus for forming a tissue fold, comprising;
 a housing; 
 an elongate pusher extending from a distal end of the housing; 
 a tubular sheath having a flat lumen adapted to receive the elongate pusher therethrough and having a proximal end which is attached to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible dial region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is disposed at an angle relative to the longitudinal axis; 
 a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath; 
 at least one anchor positioned distally of the elongate pusher; and 
 a tissue manipulation assembly comprising a first extension member and a second extension member configured to receive a tissue fold in a space located between said first and second extension members; 
 wherein said needle body has a first position in which the needle body is located outside of the space between mid first and second extension members and a second position in which the needle body is located within the space between mid first and second extension members. 
 
     
     
       19. An apparatus for forming a tissue fold, comprising;
 a housing; 
 an elongate pusher extending from a distal end of the housing; 
 a tubular sheath having a first lumen adapted to receive the elongate, pusher therethrough and having a proximal end which is attached to the housing, the tubular sheath having a flexible distal region such that the tubular sheath has a first position in which the flexible distal region extends substantially along a longitudinal axis defined by the remainder of the tubular sheath and a second position in which the flexible distal region forms an arcuate shape relative to the longitudinal axis whereby a distal end of the tubular sheath is disposed at an angle relative to the longitudinal axis; 
 a needle body disposed on a distal end of the sheath, the needle body having a second lumen therethrough in communication with the first lumen of the tubular sheath; 
 at least one anchor positioned distally of the elongate pusher; 
 a tissue manipulation assembly comprising a first jaw and a second jaw configured to receive a tissue fold in a space located between said first and second jaws; and 
 a launch tube having a distal end that is pivotably attached to said first jaw, with said tubular sheath being slidably disposed within a launch tube lumen defined by said launch tube; 
 wherein said needle body has a first position in which the needle body is located within said launch tube lumen and a second position in which the needle body extends out of the launch tube lumen.